Skip to main content
Erschienen in: Osteoporosis International 9/2013

01.09.2013 | Original Article

A conceptual and disease model framework for osteoporotic kyphosis

verfasst von: M. Bayliss, C. Miltenburger, M. White, L. Alvares

Erschienen in: Osteoporosis International | Ausgabe 9/2013

Einloggen, um Zugang zu erhalten

Abstract

Summary

This paper presents a multi-method research project to develop a conceptual framework for measuring outcomes in studies of osteoporotic kyphosis. The research involved literature research and qualitative interviews among clinicians who treat patients with kyphosis and among patients with the condition.

Introduction

Kyphosis due to at least one vertebral compression fracture is prevalent among osteoporotic patients, resulting in well-documented symptoms and impact on functioning and well-being. A three-part study led to development of a conceptual measurement framework for comprehensive assessment of symptoms, impact, and treatment benefit for kyphosis.

Methods

A literature-based disease model (DM) was developed and tested with physicians (n = 10) and patients (n = 10), and FDA guidelines were used to develop a final disease model and a conceptual framework.

Results

The DM included signs, symptoms, causes/triggers, exacerbations, and functional status associated with kyphosis. The DM was largely confirmed, but physicians and patients added several concepts related to impact on functioning, and some concepts were not confirmed and removed from the DM.

Conclusions

This study confirms the need for more comprehensive assessment of health outcomes in kyphosis, as most current studies omit key concepts.
Literatur
1.
Zurück zum Zitat Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S, O'Neill R, Kennedy DL (2007) Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 10(Suppl 2):S125–S137PubMedCrossRef Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S, O'Neill R, Kennedy DL (2007) Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 10(Suppl 2):S125–S137PubMedCrossRef
2.
Zurück zum Zitat Patrick DL, Burke LB, Gwaltney CJ, Kline Leidy N, Martin ML, Molsen E, Ring L (2011) Content validity establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2—assessing respondent understanding. Value Health 14:978–988PubMedCrossRef Patrick DL, Burke LB, Gwaltney CJ, Kline Leidy N, Martin ML, Molsen E, Ring L (2011) Content validity establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2—assessing respondent understanding. Value Health 14:978–988PubMedCrossRef
3.
Zurück zum Zitat Patrick DL, Burke LB, Gwaltney CJ, Kline Leidy N, Martin ML, Molsen E, Ring L (2011) Content validity establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1—eliciting concepts for a new pro instrument. Value Health 14:967–977PubMedCrossRef Patrick DL, Burke LB, Gwaltney CJ, Kline Leidy N, Martin ML, Molsen E, Ring L (2011) Content validity establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1—eliciting concepts for a new pro instrument. Value Health 14:967–977PubMedCrossRef
4.
Zurück zum Zitat Food and Drug Administration (2009) Guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of Health and Human Services Food and Drug Administration (2009) Guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of Health and Human Services
5.
Zurück zum Zitat Burke LB, Kennedy DL, Miskala PH, Papadopoulos EJ, Trentacosti AM (2008) The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther 84:281–283PubMedCrossRef Burke LB, Kennedy DL, Miskala PH, Papadopoulos EJ, Trentacosti AM (2008) The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther 84:281–283PubMedCrossRef
6.
Zurück zum Zitat Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B (2007) Patient-reported outcomes: conceptual issues. Value Health 10(Suppl 2):S66–S75PubMedCrossRef Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B (2007) Patient-reported outcomes: conceptual issues. Value Health 10(Suppl 2):S66–S75PubMedCrossRef
7.
Zurück zum Zitat Culham EG, Jimenez HA, King CE (1994) Thoracic kyphosis, rib mobility, and lung volumes in normal women and women with osteoporosis. Spine (Phila Pa 1976) 19:1250–1255CrossRef Culham EG, Jimenez HA, King CE (1994) Thoracic kyphosis, rib mobility, and lung volumes in normal women and women with osteoporosis. Spine (Phila Pa 1976) 19:1250–1255CrossRef
8.
Zurück zum Zitat Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR (1999) Vertebral fractures and mortality in older women: a prospective study. Study of osteoporotic fractures research group. Arch Intern Med 159:1215–1220PubMedCrossRef Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR (1999) Vertebral fractures and mortality in older women: a prospective study. Study of osteoporotic fractures research group. Arch Intern Med 159:1215–1220PubMedCrossRef
9.
Zurück zum Zitat Miyakoshi N, Kasukawa Y, Sasaki H, Kamo K, Shimada Y (2009) Impact of spinal kyphosis on gastroesophageal reflux disease symptoms in patients with osteoporosis. Osteoporos Int 20:1193–1198PubMedCrossRef Miyakoshi N, Kasukawa Y, Sasaki H, Kamo K, Shimada Y (2009) Impact of spinal kyphosis on gastroesophageal reflux disease symptoms in patients with osteoporosis. Osteoporos Int 20:1193–1198PubMedCrossRef
10.
Zurück zum Zitat Pluijm SM, Tromp AM, Smit JH, Deeg DJ, Lips P (2000) Consequences of vertebral deformities in older men and women. J Bone Miner Res 15:1564–1572PubMedCrossRef Pluijm SM, Tromp AM, Smit JH, Deeg DJ, Lips P (2000) Consequences of vertebral deformities in older men and women. J Bone Miner Res 15:1564–1572PubMedCrossRef
11.
Zurück zum Zitat Rao RD, Singrakhia MD (2003) Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Jt Surg Am 85-A:2010–2022 Rao RD, Singrakhia MD (2003) Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Jt Surg Am 85-A:2010–2022
12.
Zurück zum Zitat Sclaich C, Minne HW, Bruckner T et al (1998) Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int 8:1–7 Sclaich C, Minne HW, Bruckner T et al (1998) Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int 8:1–7
13.
Zurück zum Zitat Silverman SL (1992) The clinical consequences of vertebral compression fracture. Bone 13(Suppl 2):S27–S31PubMedCrossRef Silverman SL (1992) The clinical consequences of vertebral compression fracture. Bone 13(Suppl 2):S27–S31PubMedCrossRef
14.
Zurück zum Zitat Sinaki M (2007) The role of physical activity in bone health: a new hypothesis to reduce risk of vertebral fracture. Phys Med Rehabil Clin N Am 18:593–608PubMedCrossRef Sinaki M (2007) The role of physical activity in bone health: a new hypothesis to reduce risk of vertebral fracture. Phys Med Rehabil Clin N Am 18:593–608PubMedCrossRef
15.
Zurück zum Zitat Sinaki M, Pfeifer M, Preisinger E, Itoi E, Rizzoli R, Boonen S, Geusens P, Minne HW (2010) The role of exercise in the treatment of osteoporosis. Curr Osteoporos Rep 8:138–144PubMedCrossRef Sinaki M, Pfeifer M, Preisinger E, Itoi E, Rizzoli R, Boonen S, Geusens P, Minne HW (2010) The role of exercise in the treatment of osteoporosis. Curr Osteoporos Rep 8:138–144PubMedCrossRef
16.
Zurück zum Zitat Yamaguchi T, Sugimoto T, Yamauchi M, Matsumori Y, Tsutsumi M, Chihara K (2005) Multiple vertebral fractures are associated with refractory reflux esophagitis in postmenopausal women. J Bone Miner Metab 23:36–40PubMedCrossRef Yamaguchi T, Sugimoto T, Yamauchi M, Matsumori Y, Tsutsumi M, Chihara K (2005) Multiple vertebral fractures are associated with refractory reflux esophagitis in postmenopausal women. J Bone Miner Metab 23:36–40PubMedCrossRef
17.
Zurück zum Zitat Centre for Health Evidence (2006) Evidence-based medicine informatics project Centre for Health Evidence (2006) Evidence-based medicine informatics project
18.
Zurück zum Zitat Glaser B, Strauss AL (1967) The constant comparative methods of qualitative analysis. Discovery of grounded theory. 101–16 Glaser B, Strauss AL (1967) The constant comparative methods of qualitative analysis. Discovery of grounded theory. 101–16
19.
Zurück zum Zitat Lincoln YS, Guba EG (1985) Designing a naturalistic inquiry. Naturalistic inquiry. 221–49 Lincoln YS, Guba EG (1985) Designing a naturalistic inquiry. Naturalistic inquiry. 221–49
20.
Zurück zum Zitat Wilson IB, Cleary PD (1995) Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA 273:59–65PubMedCrossRef Wilson IB, Cleary PD (1995) Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA 273:59–65PubMedCrossRef
Metadaten
Titel
A conceptual and disease model framework for osteoporotic kyphosis
verfasst von
M. Bayliss
C. Miltenburger
M. White
L. Alvares
Publikationsdatum
01.09.2013
Verlag
Springer London
Erschienen in
Osteoporosis International / Ausgabe 9/2013
Print ISSN: 0937-941X
Elektronische ISSN: 1433-2965
DOI
https://doi.org/10.1007/s00198-013-2317-6

Weitere Artikel der Ausgabe 9/2013

Osteoporosis International 9/2013 Zur Ausgabe

Arthropedia

Grundlagenwissen der Arthroskopie und Gelenkchirurgie. Erweitert durch Fallbeispiele, Videos und Abbildungen. 
» Jetzt entdecken

Notfall-TEP der Hüfte ist auch bei 90-Jährigen machbar

26.04.2024 Hüft-TEP Nachrichten

Ob bei einer Notfalloperation nach Schenkelhalsfraktur eine Hemiarthroplastik oder eine totale Endoprothese (TEP) eingebaut wird, sollte nicht allein vom Alter der Patientinnen und Patienten abhängen. Auch über 90-Jährige können von der TEP profitieren.

Arthroskopie kann Knieprothese nicht hinauszögern

25.04.2024 Gonarthrose Nachrichten

Ein arthroskopischer Eingriff bei Kniearthrose macht im Hinblick darauf, ob und wann ein Gelenkersatz fällig wird, offenbar keinen Unterschied.

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

25.04.2024 Hypertonie Nachrichten

Beginnen ältere Männer im Pflegeheim eine Antihypertensiva-Therapie, dann ist die Frakturrate in den folgenden 30 Tagen mehr als verdoppelt. Besonders häufig stürzen Demenzkranke und Männer, die erstmals Blutdrucksenker nehmen. Dafür spricht eine Analyse unter US-Veteranen.

Ärztliche Empathie hilft gegen Rückenschmerzen

23.04.2024 Leitsymptom Rückenschmerzen Nachrichten

Personen mit chronischen Rückenschmerzen, die von einfühlsamen Ärzten und Ärztinnen betreut werden, berichten über weniger Beschwerden und eine bessere Lebensqualität.

Update Orthopädie und Unfallchirurgie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.